The process of performing a chemical or biochemical analysis on a sample often involves a series of manual measuring and transfer motions, for example opening a container, dispensing the reagent solution, drawing a predefined amount of sample from the specimen, and so on. Serial manual volumetric measurements, multiple dispensing actions, and multiple opening and closing of containers are potential points of human error, contamination, and in some case, health risk. These potential problems are particularly acute for sample collection and analysis that need to occur outside of the controlled environment of the laboratory, such as, for example the collection of environmental samples for the detection of pathogens, infectious organisms, toxins, and bio-terrorism agents, as well as of forensic samples for the detection of human identifiers carried in the DNA, and the like.
In the field of clinical diagnostics, some of these concerns are addressed by the use of air evacuated tubes, such as VACUTAINER® tubes (Becton Dickinson and Company, of Rutherford, N.J.), for the collection of blood samples. These air evacuated tubes have needle penetrable stoppers inserted therein, and prevent the blood samples from becoming contaminated. The volume of blood to be withdrawn is controlled by the amount of vacuum in the tube, usually adjusted to partially fill the tube with blood. Evacuated glass vials prepackaged with reagents are described in U.S. Pat. No. 3,873,271, which also describes admitting a sample inside the evacuated vial by a cannula mounted in a special receptacle adapted to receive the vial. The use of one or more vacuum containers, or test tubes, to withdraw sample from a single syringe is described in U.S. Pat. No. 5,097,842. Further, in clinical diagnostics, robotics and automation are applied to withdraw blood samples from VACUTAINER® or other air evacuated containers, and dispense predetermined amounts of blood into reaction mixtures for analysis. These automation devices are often fairly large and may be unwieldy for sample collection and analysis outside of the laboratory.
According to one aspect of the present disclosure, a device for receiving a fluid is provided. The device includes a fitment and a collapsible compartment coupled to the fitment. The collapsible compartment is in fluid communication with the fitment. The fitment includes a cavity formed therein, and the cavity provided under vacuum. The fitment also includes a port having a seal. The port is configured to provide fluid communication from an exterior surface of the fitment to the cavity upon opening of the seal.
Illustratively according to this aspect of the disclosure, the cavity of the device is provided with a predetermined volume and a predetermined level of vacuum to receive a predetermined volume of the fluid upon opening of the seal. The device further includes a plunger sized to be received within the cavity. Activation of the plunger forces the predetermined volume of the fluid into the collapsible compartment.
Further illustratively, the plunger includes a notch configured to provide fluid communication between the cavity and the port when the notch is adjacent the port. The plunger acts to prevent fluid communication between the cavity and the port when the notch is rotated away from the port.
Additionally illustratively, the device further includes a dried reagent which may be contained within the collapsible compartment, the cavity, or both the collapsible compartment and the cavity. The dried reagent contained within the cavity may be the same as or different from the dried reagent contained within the compartment.
According to another aspect of the disclosure, a device for receiving a fluid is provided. The device includes a fitment having a plurality of cavities formed therein. Each cavity is provided under vacuum. The fitment further includes a channel fluidly connecting the cavities, a port extending from the channel to a surface of the fitment, and a seal provided at the port. The seal is configured to maintain vacuum in the cavities.
Illustratively according to this aspect of the disclosure, the seal may be breakable or the seal may be a unidirectional valve.
Further illustratively, the cavities are provided with a predetermined volume and a predetermined amount of vacuum such that upon opening the seal a predetermined volume of the fluid is drawn into each of the cavities. The device further includes means for sealing the fluid in each of the cavities.
Additionally illustratively, the device includes a plurality of collapsible compartments affixed to the fitment. Each collapsible compartment is in fluid communication with its respective cavity.
Further illustratively, the fitment further includes a plurality of additional cavities formed therein. Each additional cavity is provided under vacuum. The fitment further includes an additional channel fluidly connecting the additional cavities, an additional port extending from each additional channel to the surface of the fitment, and an additional seal provided at each additional port. The additional seal is configured to maintain vacuum in the additional cavities. The device further includes an additional plurality of collapsible compartments affixed to the fitment.
Each additional collapsible compartment is in fluid communication with its respective additional cavity.
Illustratively, the device further includes a plurality of plungers. Each plunger is sized to be received within its respective cavity. Activation of one of the plungers forces fluid received in the respective cavity into the collapsible compartment.
Further illustratively, a removable comb of the device may be provided to engage the plungers and normally prevent activation of the plungers.
Additionally illustratively, the channel of the fitment may be etched into the surface of the fitment and covered with a barrier material.
Further illustratively, the seal of the fitment includes a punctureable portion of the barrier material.
The plurality of cavities may form a row of cavities and the fitment may further include a plurality of additional rows of cavities. Each additional cavity is provided under vacuum. The fitment may further include a plurality of additional channels and a plurality of additional ports. Each additional channel connects the cavities of a respective row of cavities. Each additional port extends from a respective channel to the surface of the fitment. The fitment further includes a plurality of additional seals. Each seal is provided at its respective port and each additional seal is configured to maintain vacuum in its respective row of additional cavities. A removable cover may be provided to cover each cavity for maintaining vacuum within the cavities. Removal of the cover exposes the cavities to surrounding atmosphere.
According to yet another aspect of the present disclosure, a device for receiving a fluid sample includes a fitment and a flexible compartment coupled to the fitment. The fitment includes a vacuum chamber configured to maintain a vacuum therein and receive the fluid sample therein, a port in communication with the vacuum chamber and configured to receive the fluid sample therethrough, and a seal blocking the port. The flexible compartment is formed to define an interior region in fluid communication with the vacuum chamber. The flexible compartment is configured to receive the fluid sample therein.
According to this aspect of the present disclosure, the seal of the fitment is frangible. Further, the fitment is made of a generally non-compressible polymer material. The flexible compartment is made of a polymer.
According to another aspect of this disclosure, the device further includes a plunger received within the vacuum chamber and movable within the vacuum chamber to adjust a volume of open space unoccupied by the plunger within the vacuum chamber. The illustrative plunger includes a first end having a notch formed therein for alignment with the port of the fitment.
According to still another illustrative aspect of this disclosure, the fitment further includes a second port in communication with the vacuum chamber and configured to communicate with the surrounding atmosphere.
According to another aspect of the present disclosure, a device is configured to maintain an air-evacuated space therein and is provided for drawing a fluid sample into the air-evacuated space. The device includes a fitment and a flexible compartment coupled to the fitment. The fitment includes a vacuum chamber configured to maintain a vacuum therein, a first passageway in communication with the vacuum chamber and configured to communicate with the surrounding atmosphere, a second passageway in communication with the vacuum chamber and configured to communicate with the surrounding atmosphere, and a frangible seal positioned to block the second passageway to prevent communication between the vacuum chamber and the surrounding atmosphere. The flexible compartment of the device is formed to define an interior region configured to receive the fluid sample therein. The interior region is positioned in fluid communication with the vacuum chamber. The device further includes a plunger received within the vacuum chamber for up and down movement within the vacuum chamber to adjust a volume of open space unoccupied by the plunger within the vacuum chamber.
According this aspect of the disclosure, the plunger includes a notch for alignment with the second passageway of the fitment. The illustrative plunger is movable between a first position to block communication between the vacuum chamber and the first passageway and a second position to block communication between the vacuum chamber and the second port.
Further illustratively according to this aspect of the disclosure, the first passageway is less than 1 mm in diameter, the second passageway is less than 1 mm in diameter, and the vacuum chamber is 5 mm in diameter.
Additionally illustratively according to this aspect of the disclosure, the flexible compartment is made of a polyvinyl material. The fitment is made of a soft polymer plastic material and the plunger is made of a rigid polymer plastic material. Further, a diameter of the plunger is substantially equal to a diameter of the vacuum chamber.
Further illustratively according to this aspect of the disclosure, the air-evacuated space has a predetermined volume and is provided with a predetermined level of vacuum for drawing in a predetermined volume of the fluid sample.
According to yet another aspect of the disclosure, a pouch assembly for receiving multiple fluid samples therein is provided. The pouch assembly includes a fitment and a plurality of flexible compartments coupled to the fitment. The fitment includes a plurality of vacuum chambers formed therein, a sample access port in communication with at least one of the plurality of vacuum chambers, and a plurality of vacuum holes. Each vacuum hole is in fluid communication with one of the plurality of vacuum chambers. Each flexible compartment of the plurality of compartments is in fluid communication with one of the plurality of vacuum chambers.
Illustratively according to this aspect of the disclosure, the sample access port is in communication with each of the plurality of vacuum chambers. The fitment further includes a passageway between the sample entry port and each of the plurality of vacuum chambers. Further illustratively, the sample access port is a plurality of sample access ports and further each sample access port is in fluid communication with one of the plurality of vacuum chambers.
Still according to another aspect of the disclosure, a method of introducing a pre-measured amount of a fluid sample into a pouch assembly is provided. The pouch assembly includes a flexible compartment and a fitment coupled to the flexible compartment. The fitment includes a vacuum-evacuated cavity in fluid communication with the flexible compartment. The method includes breaking a seal of the fitment to provide communication between the vacuum evacuated cavity and the fluid sample, allowing the fluid sample to be drawn into the cavity, and moving the fluid sample from the cavity into the flexible compartment.
Illustratively according to this aspect of the present disclosure, moving the fluid sample from the cavity into the flexible compartment includes moving a plunger positioned within the cavity to push the fluid sample from the cavity into the flexible compartment.
Further illustratively according to this aspect of the present disclosure, the method further includes the step of creating a vacuum in the cavity by placing the pouch assembly in a vacuum chamber and evacuating air from within pouch assembly through a vacuum port of the fitment. The vacuum port is in communication with the cavity. Further, the step of creating the vacuum occurs prior to the step of breaking the seal. Still further, the step of creating the vacuum further includes plugging the vacuum port once the vacuum within the cavity is approximately 7 Pa. The step of creating the vacuum further includes plugging the vacuum port by moving a plunger of the pouch assembly within the cavity to block communication between the vacuum port and the cavity. The step of creating the vacuum may further illustratively include moving a plunger of the pouch assembly within the cavity to adjust a volume of open space of the cavity unoccupied by the plunger.
According to still another aspect of the present disclosure, a method of manufacturing a pouch assembly including a flexible compartment and a fitment coupled to the flexible compartment for receiving a predetermined amount of fluid sample therein is provided. The method includes molding the fitment of the pouch assembly from a polymer plastics material to include a vacuum cavity, etching a plurality of channels into a first surface of the fitment for communication with the vacuum cavity of the fitment, and coupling a flexible compartment of the pouch assembly to the fitment. The flexible compartment is in fluid communication with the vacuum cavity.
Illustratively according to this aspect of the disclosure, the coupling step includes coupling a top layer of the flexible compartment to the first surface of the fitment to cover the plurality of channels etched into the first surface and coupling a bottom layer of the flexible compartment to a second surface of the fitment to cover an aperture of the cavity formed therein. Further illustratively, coupling the top layer of the flexible compartment includes heat sealing the top layer to the first surface; coupling the bottom layer of the flexible compartment includes heat sealing the bottom layer to the second surface of the fitment.
Additional features of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.